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Scientist - Process Development - IV*
Leadstack Inc
🇺🇸 United States
On-site
4 days ago
$50 – $63 / hour
4 days ago
Job Title: Scientist - Process Development - IV
Location: Foster City, CA 94404
Duration: 12 months Contract
Payrate: $50/hr - $73/hr on W2
Description:
- The Scientist, Biologics Pivotal Formulation and Process Development role is part of the collaborative and interdisciplinary CMC development team aiming to use state-of-the-art technologies and innovative methodologies to advance medicines into the clinic.
- The success candidate is expected to bring relevant technical expertise, contribute to key functional strategies, and spearhead innovations related to formulation and DP process development.
- S/he will have growth opportunities through acquisition of new skills, experiences, and professional relationships in a fast-paced and resource-rich environment.
Responsibilities:
- Design and execute formulation and drug product process development work packages, including formulation development, Drug Product manufacturing process development, and clinical in-use evaluations.
- Drive innovation and continuously grow technical expertise; influence internally and externally through publication, presentations, and industrial collaboration representation.
- Demonstrate understanding of analytical, biophysical characterization, or process development techniques; bring new capabilities; lead by example for lab executions.
- Fully embrace data integrity and good documentation practices for data and report generation; critically review internal and external documentation.
- Authors technical documents such as protocols, reports, regulatory dossier, etc for internal and external audience.
- Effectively collaborates with both internal and external stakeholders in project meetings.
- Support and contribute to department initiatives or cross-functional projects to drive business process excellence and scientific innovation.
Qualifications:
- Ph.D. in Pharmaceutical Science, Chemistry, Biochemistry, Chemical Engineering, or related scientific fields with 0+ years, M.S. with 6+ years, or B.S. with 8+ years of industrial experience in biologics CMC development.
- Hands-on laboratory experience required.
- Experience with formulation development, Drug Product process development, and clinical in-use evaluation for monoclonal antibodies, bispecifics, antibody-drug conjugates, fusion proteins, and other complex biologics formats strongly desired.
- Publications, external presentations, and the desire to innovate through research strongly preferred.
If you have any questions, feel free to call me on (415) 322-5419or send an email on akarsh.yathiraj@leadstackinc.com
| Thanks and Regards Akarsh Yathiraj |
| Senior Recruiter |
| C. | (415) 322-5419 |
| D. | (415) 322-5419 |
| A. | 611 Gateway Blvd, Ste 120 South San Francisco, CA 94080 |
| W. | www.leadstackinc.com |
Scientist - Process Development - IV* · Leadstack Inc